On January 15, 2020 AUM Biosciences (AUM), a Singapore-headquartered clinical-stage biotechnology company committed to speedily developing affordable cancer therapies, and Cyclica, a Toronto-based biotechnology company leveraging AI and computational biophysics to decentralize drug discovery, reported a partnership under Project Nexus to apply Cyclica’s proprietary drug discovery platform in AUM’s diverse R&D programs for the early-stage discovery of novel cancer therapies (Press release, AUM BioSciences, JAN 15, 2020, View Source [SID1234553237]).

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While there has been remarkable progress over the past few decades, cancer remains a major concern, with one in every six deaths being related to cancer. With the complex nature of cancer, researchers are faced with challenges in developing effective and affordable cancer treatments using classical drug discovery approaches, which ultimately results in barriers to affordability and availability of life-saving medicines for patients in need.

In this strategic partnership, AUM will deploy its drug development expertise, including a biomarker-driven approach, and utilize Cyclica’s integrated AI-augmented and structure-based platform, Ligand Design and Ligand Express, which together will design advanced lead-like molecules that minimize unwanted off-target effects while providing a holistic understanding of a molecule’s activity through integrated systems biology and structural pharmacogenomics.

"The ability to delve deeper into complex medical outcomes enhances the potential for discovery and assessment of novel molecules while in the development stage, which reduces the risk of failure and expedites the process," said Vishal Doshi, CEO of AUM Biosciences. "We are excited about this partnership with Cyclica, which will help us discover the undiscovered to address the needs of patients in Asia."

"Cyclica’s goal is to decentralize the discovery of medicines by partnering with hyper innovative biotechs globally. We are impressed with AUM’s expertise in drug development and our shared passion for tackling disease areas that are among the most intricate and impactful," says Cyclica’s President & CEO, Naheed Kurji.

Cyclica will receive an upfront payment as well as milestone payments upon the completion of specific stages for Project Nexus. AUM will maintain rights for future development and commercialization of drug assets resulting from Project Nexus.

On January 15, 2020 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that partnering with Eisai Co., Ltd. to develop a comprehensive liquid biopsy biomarker discovery solution for oncology, to be used by Eisai researchers at their Tsukuba Research Laboratory (Press release, Personal Genome Diagnostics, JAN 15, 2020, View Source [SID1234553236]). The goal of this collaboration is to create a kitted NGS product that will enable researchers and biopharma companies to conduct biomarker discovery work using non-invasive blood samples collected from patients in clinical trials. By delivering comprehensive genomic insights from the samples, researchers may generate clinical data repositories to gain deep insights into the molecular evolution of tumors throughout the treatment course without the need for invasive, and resource-intensive, serial tissue biopsies.

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Using DNA isolated from patient blood samples, the automated NGS solution will detect somatic alterations across more than 500 genes in cancer and drug-resistance related pathways. The profiling assay will report single nucleotide variants (SNVs), insertion/deletions, copy number alterations, rearrangements, and genomic signatures, including microsatellite instability (MSI) and tumor mutation burden. A key advantage of this solution will be the ability to provide comprehensive genomic profiling data in clinical trials where tissue is not available, and it will enable investigators to evaluate drug response dynamics and emerging mechanisms of treatment resistance.

"We are always striving to evolve and expand our liquid biopsy capabilities and believe that many innovations and insights will be discovered by interrogating blood samples using the new solution we are developing with Eisai," said, John Simmons, Ph.D., Vice President of Translational Medicine, PGDx. "Our goal is to create the tools that will provide critical oncology insights that researchers and biopharma companies need to speed the process for developing new therapies for cancer patients."

"Partnering with PGDx to develop this solution is part of our Data Driven Drug Discovery & Development (5D drug discovery) initiative to accelerate drug discovery," said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. "Utilizing digital technology, our history in drug development and PGDx’s liquid biopsy expertise, we expect this new solution will help address the complexities of developing new oncology drugs."

During the development process of this new liquid biopsy biomarker discovery solution, PGDx and Eisai will provide opportunities for researchers around the globe to join the collaboration. It is a shared goal and vision of the two companies that this solution will be utilized in clinical trials, as well as become a future standard option in clinical practice.

On January 15, 2020 Contextual Genomics, a leading cancer genomics company, and Eastern Ontario Regional Laboratory Association (EORLA), a nonprofit organization offering high quality, patient focused, hospital-based lab services in Eastern Ontario, reported that they have partnered to bring Contextual Genomics’ ctDNA cancer genomic testing to EORLA’s Champlain Local Health Integration Network (CLHIN) of Eastern Ontario, Canada (Press release, Contextual Genomics, JAN 15, 2020, View Source [SID1234553235]).

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Contextual Genomics has developed the FOLLOW IT cancer panel, a multiplex, next-generation sequencing genomic assay evaluating the mutation status of tumour DNA in plasma, identifying the somatic mutations that have the greatest potential to impact treatment decisions. EORLA will offer FOLLOW IT to its network as a part of Contextual Genomics’ FOLLOW IT Canadian Early Access Program (CEAP). Indicated patients are expected to benefit from this new option by providing a less invasive alternative to tissue biopsy and by the addition of more convenient localized blood draw collection sites.

Contextual Genomics’ Canadian Early Access Program for FOLLOW IT plasma-based genomic cancer testing is underway in British Columbia and Ontario, offering a patient-pay test for individuals with metastatic lung, breast and colorectal cancer. The FOLLOW IT panel tests for actionable mutations, potentially leading to changes in disease management. All CEAP testing is performed in the Contextual Genomics’ clinically accredited laboratory in Vancouver and results are available in 5-10 business days.

"We are excited to be providing access to FOLLOW IT testing through the Contextual Genomics’ Canadian Early Access Program," said Greg Dorion, Vice President, Operations of EORLA. "This offering is in line with EORLA’s purpose – to deliver patient-focused, consistent, high-quality and cost-effective hospital-based laboratory services to meet the needs of Eastern Ontarians."

"The partnership with EORLA, in support of our FOLLOW IT Canadian Early Access Program, is important to Canadians in this region, allowing them better access to important health care. We look forward to working with EORLA to ensure that all cancer patients in their region that would benefit from FOLLOW IT testing will have access through their hospital Network," Michael Ball, Contextual Genomics’ Chief Executive Officer, commented in a statement.

On January 15, 2020 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported that it has dosed the first patient in its Phase 1 CART-TnMUC1-01 clinical trial with the Tn/STn glycoform of mucin 1 (TnMUC1) chimeric antigen receptor T-cell (CAR-T) therapy in patients with TnMUC1-positive advanced cancers (Press release, Tmunity Therapeutics, JAN 15, 2020, View Source [SID1234553234]). This is a first-in-human trial with a CAR-T therapy targeting this antigen.

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The CART-TnMUC1 therapy was developed by a University of Pennsylvania (Penn) team led by Avery D. Posey, PhD, an assistant professor of pharmacology and a member of Penn’s Abramson Cancer Center. The MUC1 glycoprotein is a transmembrane epithelial mucin normally expressed on the apical surface of most simple glandular epithelial cells. In tumors that arise from these cells, an alternate form of MUC1 is frequently overexpressed on the cancer cell surface. The alternate form, known as TnMUC1, is depolarized and aberrantly glycosylated. Tmunity’s cell therapy specifically targets the Tn (GalNAca1-O-Ser/Thr) and sialyl-Tn (STn) (NeuAca2-6-GalNAcal-O-Ser/Thr) glycoforms of MUC1 with a fusion protein recognizing a short peptide sequence with one or two Tn O-glycans on the Ser/Thr residues. Tmunity’s CAR-T therapy also contains within its construct a novel co-stimulator region known as CD2.

"The initiation of the first trial to dose a patient with a CART-TnMUC1 represents an important milestone not only for Tmunity, but for the oncology community," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "This clinical trial marks the third program from our portfolio to enter the clinical testing phase since our company was founded in 2015. We look forward to progressing our portfolio of innovative cell therapies for high unmet need in solid tumors and advancing the potential for CAR-T therapeutics."

"The major challenge in the field of CAR-T cells is targeting solid tumors, and we have great hope that we have potentially identified a new therapeutic approach," Posey said. "Our approach, testing these ‘sweet CARs,’ is to target a sugar that is uniquely expressed in tumor cells, with the aim to develop a more effective cancer therapy."

About the CART-TnMUC1-01 Phase 1 Trial

The CART-TnMUC1-01 study is a Phase 1 trial evaluating the investigational product CART-TnMUC1 in patients with TnMUC1 positive refractory tumors in combination with a lymphodepletion chemotherapy regimen. The primary objective of the trial is to establish safety and the recommended Phase 2 dose of CART-TnMUC1 that can be administered with lymphodepletion. The trial is currently open to patients with TnMUC1-positive, treatment-resistant solid tumors, including: metastatic ovarian cancer (including cancers of the fallopian tube), pancreatic ductal adenocarcinoma, hormone receptor (HR)-negative and HER2-negative (triple negative) breast cancer (TNBC) and non-small cell lung cancer. Please refer to www.clinicaltrials.gov for additional clinical trial information.

On January 15, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company has completed dosing the last patient in the registration-enabling Cohort 4 of the C-144-01 study of lifileucel in the treatment of patients with advanced melanoma (Press release, Iovance Biotherapeutics, JAN 15, 2020, View Source [SID1234553233]). Cohort 4 has the primary endpoint of objective response rate (ORR) to be read out by an Independent Review Committee.

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"We are quite pleased to complete patient dosing of this pivotal cohort in our study of lifileucel ahead of schedule due to increased demand, bringing this potential therapy one step closer to patients," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "We remain on track to submit a Biologics License Application (BLA) subsequent to discussions with FDA, for regulatory approval of lifileucel in late 2020. Lifileucel could be the first approved cell therapy product for solid tumors."

Iovance Tumor Infiltrating Lymphocytes (TIL) for melanoma, lifileucel, is an investigational, patient-derived cell therapy that involves a 22-day manufacturing process at a centralized facility. Cohort 4 in the C-144-01 study includes post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. Lifileucel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track and Orphan Drug designations in advanced melanoma.